Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00630032
- Lead Sponsor
- UNICANCER
- Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known whether docetaxel is more effective than ixabepilone when given after surgery and combination chemotherapy in treating breast cancer.
PURPOSE: This randomized phase III trial is studying giving combination chemotherapy followed by docetaxel or ixabepilone to compare how well they work in treating patients who have undergone surgery for nonmetastatic breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* To evaluate the benefit from sequential administration of 3 courses of combination chemotherapy (FEC100) followed by 3 courses of ixabepilone versus docetaxel on the 5-year disease-free survival of women with nonmetastatic, poor-prognosis breast cancer.
Secondary
* To compare the 5-year distant metastasis-free survival.
* To compare the 5-year event-free survival.
* To compare the 5-year overall survival.
* To compare the safety profiles for the two chemotherapy regimens.
* To identify and/or validate predictive-gene expression profiles of clinical response/resistance to the two treatment regimens.
* To bank frozen and fixed tumor and frozen serum prospectively for future translational studies in both genomics and proteomics (transcriptome and proteome analyses, tissue array analyses).
* To compare the cost-effectiveness of these 2 regimens.
* To compare the quality-of-life of patients treated with these 2 regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs post-menopausal), and tumor hormone-receptor status (triple-negative vs progesterone-receptor negative, HER negative, and estrogen-receptor \[ER\] positive). Patients are randomized to 1 of 2 treatment arms.
* Docetaxel Arm: Patients receive epirubicin hydrochloride IV, fluorouracil IV, and cyclophosphamide IV every 3 weeks in courses 1-3 and docetaxel IV alone every 3 weeks in courses 4-6.
* Ixabepilone Arm: Patients receive treatment in courses 1-3 as in arm I and ixabepilone IV alone every 3 weeks in courses 4-6.
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients also complete a quality of life questionnaire periodically.
After completion of study treatment, patients are followed periodically for up to 10 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 762
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Docetaxel cyclophosphamide 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks) Docetaxel Docetaxel 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks) Docetaxel epirubicin hydrochloride 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks) Docetaxel fluorouracil 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks) Ixabepilone cyclophosphamide 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks); Ixabepilone epirubicin hydrochloride 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks); Ixabepilone fluorouracil 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks); Ixabepilone ixabepilone 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
- Primary Outcome Measures
Name Time Method Percentage of Participants With Disease-free Survival (DFS) At 5 years DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first
- Secondary Outcome Measures
Name Time Method Number of Disease-free Survival Events for Triple-negative Subgroup At 5 years DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first in participants with triple negative breast cancer only.
Number of Disease-free Survival Events for ER+/PR-/HER2- Subgroup At 5 years DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first in participants with ER+/PR-/HER2- breast cancer only.
Number of Distant Metastasis-free Survival Events for the Whole Population At 5 years The distant metastases-free survival is the length of time during and after the treatment for cancer that a patient is still alive and the cancer has not spread to other parts of the body.
Overall Survival At 5 years The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
Number of Event-free Survival At 5 years The Event-free Survival is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or the date of second neoplasia, or the date of death from any cause, whichever occurs first.
Trial Locations
- Locations (85)
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
CCOP - Colorado Cancer Research Program
🇺🇸Denver, Colorado, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Duluth Clinic Cancer Center - Duluth
🇺🇸Duluth, Minnesota, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
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